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Utilization of Products for the Development of the Pregnancy Safety Study Framework Among Mothers Linked to Live-Birth Deliveries in the Mother-Infant Linkage Table: A Descriptive Analysis

Basic Details
Date Posted
Status
Complete
Medical Product
products for the development of the pregnancy safety study framework
Health Outcome(s)
use in pregnancy
Description

In this report, we describe the utilization of various medical products during pregnancies ending in live-birth delivery where the mother is linked to a singleton infant in the Sentinel Common Data Model (SCDM) Mother‐Infant Linkage (MIL) table. Medical products of interest (MOIs) include those with pregnancy‐related postmarketing requirements (PMRs) and/or postmarketing commitments (PMCs), those involved in pregnancy registries, or those investigated in studies listed in ClinicalTrials.gov that fulfilled the following search criteria elements with respect to their use during pregnancy: 1) Pregnant, Pregnancy, Observational, 2) Limited to studies associated with a drug or biologic.

We distributed this request to four Sentinel Data Partners on March 24, 2023. The study period includes data from January 1, 2008 to June 30, 2022.

A companion analysis describes utilization of various medical products during pregnancies ending in live-birth delivery but does not utilize the Mother‐Infant Linkage (MIL) table.

Deliverables (1)
Utilization of Products for the Development of the Pregnancy Safety Study Framework Among Mothers Linked to Live-Birth Deliveries in the Mother-Infant Linkage Table: A Descriptive Analysis
Additional Details
FDA Center
CDER
Time Period
January 1, 2008 - June 30, 2022
Analysis Type
Descriptive
Population / Cohort
Females 10 to 54 years of age with evidence of a live-birth and linked to a singleton infant in the Mother Infant Linkage (MIL) table
Data Sources
Sentinel Distributed Database (SDD)
Related Links
Sentinel Drug Analysis: Utilization of Products for the Development of the Pregnancy Safety Study Framework Among Mothers with Live-Birth Deliveries: A Descriptive Analysis
Presentation: Preliminary Analysis of Drug Utilization Data to Inform the Development of the Pregnancy Safety Study Framework
Sentinel Drug Analysis: Utilization of Products Over Time for the Development of the Pregnancy Safety Study Framework Among Mothers with Live-Birth Deliveries: A Descriptive Analysis